GT719注射的临床研究复发/难治性CD19阳性成人B细胞恶性肿瘤
GT719注射的单臂，开放标签，I/II期临床研究
This study is a prospective single-arm open-labled phase I/II clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in relapsed/refractory CD19 positive adult B-cell non Hodgkin lymphoma (B-NHL) and B-acute lymphoblastic leukemia (B-ALL) patients. A total of 46 subjects (anticipated) will be enrolled in this study.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名：Dehui Zou
- 电话号码：+8613602100955
- 邮箱：zoudehui@ihcams.ac.cn
学习地点
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Tianjin Municipality
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Tianjin、Tianjin Municipality、中国
- 招聘中
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
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首席研究员：
- Dehui Zou
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接触：
- Dehui Zou
- 电话号码：+8613602100955
- 邮箱：zoudehui@ihcams.ac.cn
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.
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Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
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CD19 positivity confirmed by flow cytometry and/or histopathology.
Exclusion Criteria:
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Primary immunodeficiency.
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History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.
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Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：GT719 Injection treatment group
GT719 Injection |
GT719 Injection |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence and severity of adverse events per CTCAE 5.0
大体时间：From infusion to the end of the treatment at 12 months
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To characterize the safety profile of GT719 in patients with recurrent/refractory CD19 positive adult B-cell malignant hematological tumor as measured by the incidence and severity of adverse events per CTCAE 5.0 |
From infusion to the end of the treatment at 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Objective response rate
大体时间：28 days post the first infusion, and follow-ups at Month 2, Month 3, Month 6, Month 9 and Month 12
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To evaluate efficacy parameters such as objective response rate(ORR) assessed by the Investigator |
28 days post the first infusion, and follow-ups at Month 2, Month 3, Month 6, Month 9 and Month 12
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.